MAUDE Adverse Event Report: HS HOSPITAL SERVICE S.P.A. TRAPSYSTEM; INSTRUMENT, BIOPSY

Lot Number 25539

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

During a bone marrow biopsy procedure the core needle bent at approximately a 45 degree angle.The physician was able to get an acceptable sample, so the patient was not harmed.

• Brand Name: TRAPSYSTEM
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HS HOSPITAL SERVICE S.P.A.; 6600 w. rogers circle; suite 1 & 2; boca raton FL 33487
• MDR Report Key: 5856166
• MDR Text Key: 51495981
• Report Number: 5856166
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/12/2021
• Device Lot Number: 25539
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR